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US legislative update: takeaways for European pharma

European Pharmaceutical Review

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. Citizen Petitions before the FDA. 2 Submission of a Citizen Petition to the FDA obligates the regulator to address the arguments raised. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

In the case of Novartis’ antihypertensive drug Exforge (amlodipine and valsartan), retail pharmacies including CVS, Walgreens, and two other plaintiff groups accused Novartis and Endo International’s Par Pharmaceutical unit of forming an illegal “reverse payment” agreement to delay the launch of less expensive generic versions of the drug.

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The Future of RWE in Clinical Trial Design and Recruitment

Clarify Health

Drouin, the moderator, added to the discussion: “Five years ago, it was not possible to bring together 300 million lives annually of patient journey data with claims, lab, prescription, and social determinants data linked at the patient level. Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence?

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The Future of RWE in Clinical Trial Design and Recruitment

Clarify Health

Drouin, the moderator, added to the discussion: “Five years ago, it was not possible to bring together 300 million lives annually of patient journey data with claims, lab, prescription, and social determinants data linked at the patient level. Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence?

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FDA clears way for retail pharmacy sale of abortion pills

pharmaphorum

Retail pharmacies in the US will be able to dispense mifepristone-based therapies to end pregnancies after the FDA introduced changes to its regulatory framework for the products. The American College of Obstetricians and Gynaecologists (ACOG) said the FDA’s decision was a victory for women’s health.

Retail 97
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Industry Briefs November 2022

PM360

The two retail pharmacy giants have announced their intention to settle lawsuits regarding inappropriate opioid prescriptions at $5 billion each. Ketamine is FDA approved for anesthesia and pain management but not for depression or any other psychiatric disorder. CVS and Walgreens Announce Opioid Settlements. Local and U.S.

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OTC Narcan will cost ‘less than $50’, company says

Pharmaceutical Technology

The company has said its goal is to have an out-of-pocket retail price that is in line with its publick interest pricing strategy. Additionally, its pricing for both public interest groups and retailers going forward would be less than the current Wholesale Acquisition Cost (WAC) price of $125.